Arcoxia

Arcoxia

etoricoxib

Manufacturer:

Organon

Distributor:

Zuellig Pharma

Marketer:

A.Menarini
Concise Prescribing Info
Contents
Etoricoxib
Indications/Uses
Acute & chronic treatment of OA & RA. Ankylosing spondylitis (AS), acute gouty arthritis, primary dysmenorrhea & moderate to severe acute post-op pain associated w/ abdominal gynecological surgery. Relief of chronic musculoskeletal pain including chronic low back pain & acute pain associated w/ dental surgery.
Dosage/Direction for Use
OA 30 mg or 60 mg once daily. Max: 60 mg daily. RA & AS 60 mg or 90 mg once daily. Min effective dose: 60 mg once daily. Max: 90 mg daily. Acute pain 90 mg or 120 mg once daily to max 8 days. Max: 120 mg daily. Acute gouty arthritis & primary dysmenorrhea Recommended & max dose: 120 mg once daily. Chronic musculo-skeletal pain, including chronic low back pain Recommended & max dose: 60 mg once daily. Post-op dental pain Recommended & max dose: 90 mg once daily. Post-op gynecological pain Administer initial dose shortly before surgery. Recommended dose: 90 mg once daily. May be increased to max 120 mg once daily. Max: 120 mg daily. Mild hepatic insufficiency (Child-Pugh score 5-6) Max: 60 mg once daily. Moderate hepatic insufficiency (Child-Pugh score 7-9) Reduce dose to 30 mg once daily. Max: 60 mg every other day.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Patients w/ active peptic ulceration or GI bleeding; who have developed signs of asthma, acute rhinitis, nasal polyps, angioneurotic oedema or urticaria following administration of aspirin or other NSAIDs; w/ inflammatory bowel disease; MI or CHF (NYHA II-IV), HTN w/ inadequately controlled BP, established & history of ischemic heart disease, peripheral arterial &/or cerebrovascular disease (including recent CABG surgery or angioplasty); history of paralysis from cerebrovascular disease. Severe hepatic dysfunction (Child-Pugh score >9). Patients w/ estimated CrCl <30 mL/min. Pregnancy & lactation. Childn <16 yr.
Special Precautions
Discontinue if persistently abnormal LFTs (3x ULN) are detected; if elderly or patients w/ renal, hepatic or cardiac dysfunction deteriorate during treatment; at 1st appearance of skin rash, mucosal lesions or other signs of hypersensitivity. Increased risk for thrombotic events (especially MI & stroke); GI adverse effects (GI ulceration or other GI complications) when taken concomitantly w/ ASA (even at low doses); skin reactions in patients w/ history of any drug allergy. Patients w/ risk factors for CV events eg, HTN, hyperlipidaemia, DM, smoking; considerable dehydration; preexisting edema, HTN or heart failure. Patients using any other NSAID or ASA concomitantly or patients w/ prior history of GI disease, eg, ulceration & GI bleeding; who have previously experienced acute asthmatic attacks, urticaria, or rhinitis precipitated by salicylates or non-selective COX inhibitors. Not a substitute for aspirin for CV prophylaxis. New onset or recurrent CHF. Elevated ALT & AST. May mask fever. Periodically re-evaluate need for symptomatic relief & response to therapy. Monitor renal function in patients w/ preexisting significantly renal function impairment, uncompensated heart failure or cirrhosis; BP during treatment. Evaluate for persistently abnormal LFTs patient w/ symptoms &/or signs suggesting liver dysfunction, or in whom abnormal LFT has occurred. Rehydrate patients prior to starting therapy. Severe hepatic insufficiency (Child-Pugh score >9). Not recommended in advanced renal disease (CrCl <30 mL/min). Not recommended in woman attempting to conceive. Discontinue if woman becomes pregnant during treatment. Not recommended in pregnancy (from 20 wk gestation onwards). Not to be given in ped patients. Elderly.
Adverse Reactions
Asthenia/fatigue, dizziness, oedema/fluid retention, lower extremity edema, flu-like disease, HTN, abdominal pain, flatulence, diarrhea, dyspepsia, heartburn, epigastric discomfort, nausea, headache, increased ALT & AST. SJS, TEN.
Drug Interactions
Increased prothrombin time INR w/ warfarin. Decreased AUC w/ rifampin. Increased plasma conc & reduced renal clearance of MTX. Diminished antihypertensive effect of diuretics, ACE inhibitors & AIIA. Increased plasma lithium levels. Increased rate of GI ulceration or other complications w/ low-dose aspirin. Increased nephrotoxic effect of cyclosporin & tacrolimus. Increased steady state AUC0-24hr of OC containing ethinyl estradiol & norethindrone; HRT. Increased digoxin Cmax. Increased serum conc of ethinyl estradiol. Concomitant administration w/ drugs primarily metabolised by human sulfotransferases eg, oral salbutamol & minoxidil.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AH05 - etoricoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
Presentation/Packing
Form
Arcoxia tab 120 mg
Packing/Price
30's
Form
Arcoxia tab 30 mg
Packing/Price
30's
Form
Arcoxia tab 60 mg
Packing/Price
30's
Form
Arcoxia tab 90 mg
Packing/Price
30's
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